US Drug Recall Register
Class II · Moderate risk Terminated Initiated May 15, 2013 (13 years ago)

Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.

What was recalled

Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in 555mL bag, Pentec Health Inc, 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

Recalling firm
Pentec Health
Origin
PA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-588-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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